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DK3277278T3 - Kombinationsdoseringsform af en my-opioid receptorantagonist og et opioid - Google Patents

Kombinationsdoseringsform af en my-opioid receptorantagonist og et opioid Download PDF

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Publication number
DK3277278T3
DK3277278T3 DK16718062.9T DK16718062T DK3277278T3 DK 3277278 T3 DK3277278 T3 DK 3277278T3 DK 16718062 T DK16718062 T DK 16718062T DK 3277278 T3 DK3277278 T3 DK 3277278T3
Authority
DK
Denmark
Prior art keywords
myopioid
opioid
dosage form
receptor antagonist
combination dosage
Prior art date
Application number
DK16718062.9T
Other languages
English (en)
Inventor
Shaoling Li
Manshiu Leung
Hao Zhang
Venkat R Thalladi
Yun Mo
Original Assignee
Theravance Biopharma R&D Ip Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Theravance Biopharma R&D Ip Llc filed Critical Theravance Biopharma R&D Ip Llc
Application granted granted Critical
Publication of DK3277278T3 publication Critical patent/DK3277278T3/da

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/468-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/439Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom the ring forming part of a bridged ring system, e.g. quinuclidine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
DK16718062.9T 2015-04-02 2016-03-31 Kombinationsdoseringsform af en my-opioid receptorantagonist og et opioid DK3277278T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562141981P 2015-04-02 2015-04-02
PCT/US2016/025176 WO2016161069A1 (en) 2015-04-02 2016-03-31 Combination dosage form of a mu opioid receptor antagonist and an opioid agent

Publications (1)

Publication Number Publication Date
DK3277278T3 true DK3277278T3 (da) 2020-04-06

Family

ID=55806767

Family Applications (1)

Application Number Title Priority Date Filing Date
DK16718062.9T DK3277278T3 (da) 2015-04-02 2016-03-31 Kombinationsdoseringsform af en my-opioid receptorantagonist og et opioid

Country Status (27)

Country Link
US (4) US20160287573A1 (da)
EP (1) EP3277278B1 (da)
JP (2) JP6713483B2 (da)
KR (1) KR20170132325A (da)
CN (1) CN107820424B (da)
AU (1) AU2016243691A1 (da)
BR (1) BR112017021120A2 (da)
CA (1) CA2980328A1 (da)
CY (1) CY1122828T1 (da)
DK (1) DK3277278T3 (da)
ES (1) ES2774473T3 (da)
HK (1) HK1247105A1 (da)
HR (1) HRP20200432T1 (da)
HU (1) HUE048785T2 (da)
IL (1) IL254593A0 (da)
LT (1) LT3277278T (da)
ME (1) ME03671B (da)
MX (1) MX2017012474A (da)
PH (1) PH12017501767A1 (da)
PL (1) PL3277278T3 (da)
PT (1) PT3277278T (da)
RS (1) RS60074B1 (da)
RU (1) RU2017134794A (da)
SI (1) SI3277278T1 (da)
SM (1) SMT202000157T1 (da)
TW (1) TW201642856A (da)
WO (1) WO2016161069A1 (da)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2980328A1 (en) 2015-04-02 2016-10-06 Theravance Biopharma R&D Ip, Llc Combination dosage form of a mu opioid receptor antagonist and an opioid agent
JP7222244B2 (ja) 2017-08-08 2023-02-15 三菱ケミカル株式会社 医薬錠剤、およびその製造方法

Family Cites Families (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT1041987E (pt) 1997-12-22 2006-07-31 Euro Celtique Sa Forma farmaceutica de dosagem oral, compreendendo uma combinacao de um agonista de opioide e naltrexona
US6419960B1 (en) 1998-12-17 2002-07-16 Euro-Celtique S.A. Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations
US6451806B2 (en) 1999-09-29 2002-09-17 Adolor Corporation Methods and compositions involving opioids and antagonists thereof
AR029538A1 (es) * 2000-07-06 2003-07-02 Wyeth Corp Composiciones farmaceuticas de agentes estrogenicos
US7842307B2 (en) 2001-08-06 2010-11-30 Purdue Pharma L.P. Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent
NZ530971A (en) * 2001-08-06 2004-08-27 Euro Celtique S Oral dosage forms comprising an opioid agonist with releasable and sequestered opioid antagonists
EP1572164A2 (en) * 2002-12-18 2005-09-14 Pain Therapeutics, Inc. Oral dosage forms with therapeutically active agents in controlled release cores and immediate release gelatin capsule coats
US20050013863A1 (en) 2003-07-18 2005-01-20 Depomed, Inc., A Corporation Of The State Of California Dual drug dosage forms with improved separation of drugs
CA2540308C (en) 2003-09-26 2013-08-06 Alza Corporation Drug coating providing high drug loading and methods for providing the same
TWI354569B (en) 2004-05-28 2011-12-21 Bristol Myers Squibb Co Coated tablet formulation and method
EP1871772B1 (en) * 2005-03-02 2014-09-10 Theravance, Inc. Quinolinone compounds as 5-ht4 receptor agonists
MY145633A (en) 2006-03-01 2012-03-15 Theravance Inc 8-azabicyclo[3.2.1]octane compounds as mu opioid receptor antagonists
CN101395154B (zh) * 2006-03-01 2011-01-19 施万制药 作为μ阿片受体拮抗剂的8-氮杂双环[3.2.1]辛烷化合物
CN101500542A (zh) * 2006-07-11 2009-08-05 共有药物有限公司 控释制剂
TWI409067B (zh) 2007-02-28 2013-09-21 Theravance Inc 8-氮雜雙環〔3.2.1〕辛烷化合物之結晶型
TWI415850B (zh) 2007-07-20 2013-11-21 Theravance Inc 製備mu類鴉片受體拮抗劑之中間物的方法
AU2009244190B2 (en) * 2008-05-07 2016-02-25 Salix Pharmaceuticals, Ltd. Methods of treating bowel disease by administering a bowel cleanser and an antibiotic
EP2210595A1 (en) 2009-01-14 2010-07-28 LEK Pharmaceuticals d.d. Active coating of pharmaceutical dosage forms
BRPI1007725A2 (pt) * 2009-05-12 2016-02-16 Bpsi Holdings Llc composição de revestimento de liberação imediata com propriedades melhoradas de barreira à umidade, suspensão aquosa, substrato oral revestido, forma de dosagem oral e método para preparação da mesma
IT1398930B1 (it) * 2010-03-24 2013-03-28 Molteni & C Formulazioni farmaceutiche bistrato contenenti agonisti ed antagonisti oppioidi.
MX2013002146A (es) * 2010-09-03 2013-04-03 Astrazeneca Uk Ltd Formulaciones farmaceuticas que utilizan antioxidantes solubles en agua.
RU2607480C2 (ru) 2011-02-01 2017-01-10 Бристол-Майерс Сквибб Компани Фармацевтические композиции, содержащие аминосоединение
US9339489B2 (en) * 2013-03-15 2016-05-17 Aprecia Pharmaceuticals Company Rapid disperse dosage form containing levetiracetam
CA2980328A1 (en) 2015-04-02 2016-10-06 Theravance Biopharma R&D Ip, Llc Combination dosage form of a mu opioid receptor antagonist and an opioid agent

Also Published As

Publication number Publication date
US20160287573A1 (en) 2016-10-06
SMT202000157T1 (it) 2020-05-08
US20190321350A1 (en) 2019-10-24
AU2016243691A1 (en) 2017-10-12
ES2774473T3 (es) 2020-07-21
HK1247105A1 (zh) 2018-09-21
US10369142B2 (en) 2019-08-06
US20210161884A1 (en) 2021-06-03
SI3277278T1 (sl) 2020-04-30
EP3277278A1 (en) 2018-02-07
US10946009B2 (en) 2021-03-16
MX2017012474A (es) 2018-01-11
RU2017134794A (ru) 2019-04-04
JP2018513138A (ja) 2018-05-24
CN107820424A (zh) 2018-03-20
US20180050028A1 (en) 2018-02-22
PH12017501767A1 (en) 2018-06-11
US11452723B2 (en) 2022-09-27
CY1122828T1 (el) 2021-05-05
JP2020073583A (ja) 2020-05-14
CA2980328A1 (en) 2016-10-06
EP3277278B1 (en) 2020-01-08
BR112017021120A2 (pt) 2018-07-03
LT3277278T (lt) 2020-03-25
HUE048785T2 (hu) 2020-08-28
HRP20200432T1 (hr) 2020-06-12
RS60074B1 (sr) 2020-05-29
ME03671B (me) 2020-10-20
IL254593A0 (en) 2017-11-30
KR20170132325A (ko) 2017-12-01
CN107820424B (zh) 2020-07-28
JP6713483B2 (ja) 2020-06-24
PL3277278T3 (pl) 2020-07-27
PT3277278T (pt) 2020-04-16
WO2016161069A1 (en) 2016-10-06
TW201642856A (zh) 2016-12-16

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